Day and Night Closed-loop in Young People With Type 1 Diabetes (DAN05)
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c.
This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 12 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group).
It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy.
Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 12 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).
|Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Endocrine System Diseases Autoimmune Diseases||Device: FlorenceM Device: Insulin pump therapy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||An Open-label, Multi-centre, Randomized, Single-period, Parallel Study to Assess the Efficacy, Safety and Utility of 12 Month Day-and-night Automated Closed-loop Insulin Delivery Under Free Living Conditions Compared to Insulin Pump Therapy in Children and Adolescents With Type 1 Diabetes|
- The primary outcome is the centralised measurement of glycated haemoglobin (HbA1c) at 12 months. [ Time Frame: HbA1c will be taken at baseline, 3, 6, 9 and 12 months ]The objective is to assess efficacy of day and night automated closed-loop glucose control combined with low glucose feature in improving HbA1c, as compared with insulin pump therapy alone.
- Time spent in the target glucose range (3.9 to 10mmol/l) (70 to 180mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time spent below target glucose (3.9mmol/l)(70mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time spent above target glucose (10.0 mmol/l) (180 mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Mean and standard deviation or percentiles sensor glucose [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Coefficient of variation of glucose levels [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time with glucose levels < 3.5 mmol/l (63 mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time with glucose levels <2.8 mmol/l (50 mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Changes in total basal and bolus insulin dose [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on CRF and insulin pump data.
- AUC of glucose below 3.5mmol/l (63mg/dl) [ Time Frame: 12 months ]Secondary endpoints regarding glucose levels will be based on sensor glucose data.
- Safety Evaluation [ Time Frame: 12 months ]Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association (adolescents), and International Society for Pediatric and Adolescent Diabetes (children), frequency of diabetic ketoacidosis (DKA), frequency of severe hyperglycaemia (>16.7 mmol/l)(>300mg/dl) with significant ketosis (plasma ketones >0.6mmol/l) and nature and severity of other adverse events
- Utility evaluation [ Time Frame: 12 months ]Assessment of the frequency and duration of use of the closed-loop system
- Human Factors Assessment [ Time Frame: 12 months ]Cognitive, emotional, and behavioural characteristics of participating subjects and family members and their response to the closed-loop system and clinical trial will be assessed gathering both quantitative (validated surveys) and qualitative data (focus groups)
- Health Economic Evaluation [ Time Frame: 12 months ]Cost utility analysis on the benefits of closed loop insulin delivery to inform reimbursement decision-making
|Anticipated Study Start Date:||April 2017|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: 24/7 closed loop insulin delivery
The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed, and (3) an insulin pump that delivers the insulin. The name of this closed-loop system is FlorenceM. Half of the individuals taking part in the study will use the study system for 12 months.
The automated closed loop system (FlorenceM) will consist of:
Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 CGM and glucose suspend feature.
An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.
Active Comparator: Insulin pump therapy
Half of the Subjects will continue using their own insulin pump for 12 months.
Device: Insulin pump therapy
Subjects will continue using their own insulin pump for 12 months.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02925299
|Contact: Roman Hovorka, PhD||+44 1223 762 email@example.com|
|Contact: Judy Sibayan, MPH, CCRPfirstname.lastname@example.org|
|United States, California|
|Stanford University||Not yet recruiting|
|Palo Alto, California, United States, 95032|
|Contact: Bruce Buckingham, MD 650-725-6549 email@example.com|
|Contact: Liana Hsu, RN 650-735-3939 firstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Denver School of Medicine Barbara Davis Center||Not yet recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Paul Wadwa, MD 303-724-6742 Laurel.Messer@ucdenver.edu|
|Contact: Laurel Messer, RN, MPH, CDE (303) 724-6742 Laurel.Messer@ucdenver.edu|
|United States, Connecticut|
|Yale University||Not yet recruiting|
|Hartford, Connecticut, United States, 06520|
|Contact: Stuart Weinzimer 203-785-7924 email@example.com|
|Contact: Lori Carria 203-737-3595 firstname.lastname@example.org|
|United States, Minnesota|
|International Diabetes Center at Park Nicollet||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55146|
|Contact: Amy Criego 952-993-1913 Mary.L.Johnson@ParkNicollet.com|
|Contact: Mary L. Johnson, RN 952-993-1913 Mary.L.Johnson@ParkNicollet.com|
|University of Cambridge||Not yet recruiting|
|Cambridge, Cambridgeshire County, United Kingdom, CB2 0QQ|
|Contact: Carlo Acerini, MD +44 (0)1223 336 865 email@example.com|
|Contact: Martin Tauschmann, MD +44 (0) 1223-769-080 firstname.lastname@example.org|
|Principal Investigator: Carlo Acerini, MD|
|The Leeds Teaching Hospitals NHS Trust||Not yet recruiting|
|Leeds, West Yorkshire, United Kingdom, LS9 7TF|
|Contact: Fiona Campbell, MD 44-1132-064-996 Jane.email@example.com|
|Contact: Jane Exall 44-1132-064-996 Jane.firstname.lastname@example.org|
|Study Chair:||Roman Hovorka, PhD||University of Cambridge|
|Principal Investigator:||Carlo Acerini, MD||University of Cambridge|
|Principal Investigator:||Fiona Campbell, MD||The Leeds Teaching Hospitals NHS Trust|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|
|Principal Investigator:||Stuart Weinzimer, MD||Yale University|
|Principal Investigator:||Amy Criego, MD||International Diabetes Center at Park Nicollet|
|Principal Investigator:||Paul Wadwa, MD||University of Colorado Denver School of Medicine Barbara Davis Center|
|Principal Investigator:||Korey Hood, PhD||Stanford University|
|Principal Investigator:||Dana Goldman, PhD||University of Southern California|